Recall Z-0493-05 ยท HIH Hysteroscope (And Accessories)
Ethicon, Inc
VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US Distribution/Manufactured for GYNECARE, A division of Ethicon, Inc., a Johnson & Johnson Company, Somerville, NJ 08876. The product subject of this recall is the connector cable which goes between the electrosurgical generator and the elctrode used for surgery. Specifically, the recall focuses on the hand
| Date | Feb 2, 2005 (initiated Dec 16, 2004) |
| Status | Terminated |
| Reason | Deformation of the Verspoint Hysteroscopic System Connector Cable hand grips when autoclaved causing possible non-sterile electrodes. |
| Root cause | Nonconforming Material/Component |
| Action | The recall letter was mailed to the Director of Material Management and the Director of Operating Room on December 14, 2004. |
| Quantity | 891electrodes |
| Distribution | Ethicon distributed the devices to 166 hospitals in the US. There are no Government sales. Product sold to other countries was distributed directly from the manufacturerin England to Ethicon distributors outside the US. The Foreign countries with accounts are: Austria, Czech Republic, Greece, It |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962482 | SCUBA SYSTEM Gynecare, Inc., Nov 1, 1996 |